Coya Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for COYA 302, an investigational biologic combination therapy being developed to treat amyotrophic lateral sclerosis (ALS).
The designation is intended to expedite the development and review processes for therapies addressing serious or life-threatening conditions.
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The fast track programme provides several regulatory benefits, including more frequent FDA meetings, the option for rolling review of marketing applications, and eligibility for expedited approval pathways such as accelerated approval and priority review.
These measures aim to facilitate quicker access to promising therapies for patients with limited treatment options.
Coya Therapeutics CEO Arun Swaminathan said: “We are pleased to announce that COYA 302 has received FDA Fast Track designation for the treatment of ALS. This recognition underscores the devastating nature of ALS and the urgent need for new therapies.
“At Coya, we remain fully committed to advancing our lead biologic candidate, COYA 302, through the regulatory process with the ultimate goal of delivering, pending FDA approval, a safe and effective treatment for patients living with ALS and their families.”
COYA 302 is a proprietary biologic combination therapy that utilises a dual immunomodulatory approach.
It is designed to boost the anti-inflammatory function of regulatory T cells (Tregs) and reduce inflammation driven by activated monocytes and macrophages, employing low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig.
The therapy is being developed for subcutaneous administration in ALS patients, with the mechanisms potentially offering additive or synergistic therapeutic effects.
Coya Therapeutics is currently conducting the ALSTARS Trial, a Phase II, randomised, multi-centre, double-blind, placebo-controlled clinical study to assess the efficacy and safety of COYA 302 in patients with ALS.
COYA 302 remains an investigational product and has not been approved by the FDA or any other regulatory agency.
In January 2024, Coya Therapeutics expanded its development plans to evaluate its lead combination therapy, COYA 302, not only in ALS but also in frontotemporal dementia and Parkinson’s disease.
